Recall archive / FDA device enforcement
Neria Soft Infusion Set, Product Code 507302, intravascular administration set — FDA record Z-1544-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Reason
- Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
- Classification
- Class II
- Recalling firm
- Unomedical A/S
- Quantity
- 10,770 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1544-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of Florida.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 24, 2024
- Recall initiation date
- Mar 5, 2024
- Center classification date
- Apr 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.